The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Scholar Patient Monitor.
| Device ID | K944860 |
| 510k Number | K944860 |
| Device Name: | SCHOLAR PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Contact | Alex Kaplan |
| Correspondent | Alex Kaplan CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-06-20 |